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SPRYCEL
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

SPRYCEL Rx

Generic Name and Formulations:
Dasatinib 20mg, 50mg, 70mg, 80mg, 100mg, 140mg; tabs.

Company:
Bristol-Myers Squibb

Therapeutic Use:

Indications for SPRYCEL:

Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib in adults. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy in adults. Newly-diagnosed Ph+ ALL in combination with chemotherapy in children.

Adult:

Swallow whole. Chronic phase CML: 100mg once daily; may increase to 140mg once daily if unable to achieve hematologic or cytogenic response. Continue until disease progression or unacceptable toxicity. Accelerated phase CML, myeloid or lymphoid blast CML, Ph+ ALL: 140mg once daily; may increase to 180mg once daily. Avoid concomitant strong CYP3A4 inhibitors; if unavoidable, consider reducing Sprycel dose (see full labeling). Avoid concomitant strong CYP3A4 inducers; if unavoidable, consider increasing Sprycel dose (monitor). Dose adjustments for toxicity: see full labeling.

Children:

Swallow whole. <1yr or <10kg: not recommended. ≥1yr: Chronic phase CML: 10–<20kg: initially 40mg once daily; may increase to max 50mg/day. 20–<30kg: initially 60mg once daily; may increase to max 70mg/day. 30–<45kg: initially 70mg once daily; may increase to max 90mg/day. ≥45kg: initially 100mg once daily; may increase to max 120mg/day. Continue until disease progression or unacceptable toxicity. Ph+ ALL (initiate on or before Day 15 of induction chemotherapy when diagnosis confirmed): 10–<20kg: 40mg once daily; 20–<30kg: 60mg once daily; 30–<45kg: 70mg once daily; ≥45kg: 100mg once daily. Continue for max 2yrs. Both: recalculate dose every 3 months based on changes in body weight. Avoid concomitant strong CYP3A4 inhibitors; if unavoidable, consider reducing Sprycel dose (see full labeling). Avoid concomitant strong CYP3A4 inducers; if unavoidable, consider increasing Sprycel dose (monitor). Dose adjustments for toxicity: see full labeling.

Warnings/Precautions:

Risk of severe myelosuppression. Obtain CBCs every 2 weeks for 12 weeks, then every 3 months thereafter (chronic phase CML) or weekly for the first 2 months, then monthly thereafter (advanced phase CML or Ph+ ALL). In children with Ph+ ALL on combination chemotherapy, obtain CBCs before starting each block of chemotherapy and as clinically indicated; do every 2 days until recovery during consolidation. Monitor for signs/symptoms of cardiac dysfunction; treat appropriately if occur. Congenital long QT syndrome. Proarrhythmic conditions. Cumulative high-dose anthracycline therapy. Hypokalemia, hypomagnesemia; correct electrolyte imbalances before starting and during therapy. Monitor for pleural effusions. Increased risk of pulmonary arterial hypertension (PAH); evaluate for signs/symptoms of underlying cardiopulmonary disease before and during treatment; permanently discontinue if occurs. Permanently discontinue if severe skin reactions (eg, Stevens-Johnson syndrome) occur. Increased risk of tumor lysis syndrome in advanced stage disease and/or high tumor burden. Maintain adequate hydration. Correct uric acid levels before therapy and monitor electrolytes. Hepatic impairment. Elderly. Embryo-fetal toxicity. Pregnancy: avoid. Advise females of reproductive potential to use effective contraception during and for 30 days after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Pharmacological Class:

Kinase inhibitor.

Interactions:

May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole), grapefruit juice; see Adults. May be antagonized by strong CYP3A4 inducers (eg, rifampin), St. John's wort; see Adults. Separate dosing of antacids by at least 2hrs; H2 blockers, proton pump inhibitors: not recommended. Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants. Caution with antiarrhythmics or other drugs that may lead to QT prolongation.

Adverse Reactions:

Myelosuppression, fluid retention, diarrhea, headache, dyspnea, musculoskeletal pain, rash, fatigue, nausea, severe hemorrhage (eg, CNS, GI); QT prolongation, cardiac events, PAH, severe skin reactions. Also in children: effects on bone growth and development (monitor).

Generic Availability:

NO

How Supplied:

Tabs 20mg, 50mg, 70mg—60; 80mg, 100mg, 140mg—30

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